AzTrials
AzTrials

Renal Pelvis and Ureter Urothelial CarcinomaPhase 2/3NCT04628767

Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer

A Phase 2/3 study testing Biopsy Procedure, Biospecimen Collection and Cisplatin in people with Renal Pelvis and Ureter Urothelial Carcinoma, run by National Cancer Institute (NCI) at 258 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy Procedure, Biospecimen Collection and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
258 sitesUnited States
Study dates
12 Nov 2021to 30 Sep 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • STEP 1 REGISTRATION AND RANDOMIZATION
  • Patients must be >= 18 years of age
  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
  • Patient must have a diagnosis of high grade upper tract urothelial carcinoma expected within 14 weeks (98 days) prior to registration/randomization with one of the following:
  • Biopsy (gold standard, preferred) and either upper urinary tract mass on cross-sectional imaging or tumor directly visualized during upper urinary tract endoscopy
  • High grade cytology and clinically estimated invasive upper urinary tract mass on cross-sectional imaging (e.g., including presence of tumor-related hydronephrosis) or tumor directly visualized during upper urinary tract endoscopy
Show all 66Show fewer
  • NOTE: Universal histologic testing of UTUC with additional studies, such as immunohistochemistry and/or microsatellite instability, is strongly recommended to identify patients with high probability of Lynch-related or other germline mutation related cancers whom clinicians should refer for genetic counseling and germline testing (this is not required for eligibility)
  • Due to the anatomy of upper urinary tract and lack of muscularis propria, pathologic evidence of cT2 on biopsy is usually not possible
  • Patients must not have any component of small cell/neuroendocrine carcinoma. Other histologic subtypes (variants) are permitted provided the half or predominant (>= 50%) subtype is conventional urothelial carcinoma
  • Leukocytes >= 3,000/mcL (obtained =< 14 days prior to registration/randomization)
  • Platelets >= 100,000/mcL (obtained =< 14 days prior to registration/randomization)
  • Total bilirubin =< 1.2 mg/dL (or ≤ 2 mg/dL for patients with Gilbert's disease)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2 x institutional ULN (obtained =< 14 days prior to registration/randomization)
  • Hemoglobin (Hgb) >= 9 g/dL (obtained =< 14 days prior to registration/randomization)
  • NOTE: Packed red blood transfusion is allowed to achieve this parameter as per treating investigator
  • Patients must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A patient of childbearing potential is defined as any patient, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Patients of childbearing potential and sexually active patients must not expect to conceive or father children, either by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of registration, while on study treatment and for at least 6 months after the last dose of protocol treatment
  • Patients must have no evidence of metastatic disease or clinically enlarged regional lymph nodes (>= 1.5 cm short axis) on imaging required within 28 days prior to registration (Non-regional findings >=1.5 cm short axis that in the opinion of the investigator are not concerning for involvement based on radiographic characteristics, chronicity, avidity on positron emission tomography (PET) scan or other imaging or other criteria can be eligible based on investigator discretion).
  • NOTE: Patients with elevated alkaline phosphatase, calcium or suspicious bone pain/tenderness can also undergo baseline bone scan to evaluate for bone metastasis at the discretion of local provider.
  • Patient must meet below criteria for prior/current malignancy history:
  • Non-urothelial cancer malignancy history:
  • Patient must not have another active (or within two years) second malignancy other than resected non-melanoma skin cancers, resected in situ breast, cervical or other in situ carcinoma, and either clinically insignificant per the investigator (e.g. =< Gleason 3+4) on active surveillance (or watchful waiting) or previously treated prostate cancer with no rising prostate specific antigen (PSA) and no plan to treat
  • NOTE: Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Urothelial cancer malignancy history:
  • Patient may have a history of resectable urothelial cancer as long as patients meet one of the following:
  • T0, Ta or Tis at any time
  • T1-4a N0 and no evidence of disease (NED) for more than 2 years from the latest therapy [e.g., radical surgery, transurethral resection of bladder tumor (TURBT), radiation, chemotherapy (neoadjuvant or adjuvant, or with radiation)]. Prior systemic immune checkpoint inhibitor is not allowed.
  • Patient with history of >= pT4b, N+, and/or M1 UC is not eligible.
  • NOTE: Patients in whom concomitant or prior bladder/urethra predominant (>= 50%) urothelial carcinoma have been surgically resected and demonstrated to be only Ta or carcinoma in situ (CIS) (< cT1 N0) are eligible regardless of time elapsed
  • Patient must not have any uncontrolled illness including, but not limited to, ongoing or active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), symptomatic congestive heart failure (CHF), myocardial infarction (MI) or unstable angina pectoris, significant uncontrolled cardiac arrhythmia, clinically relevant liver cirrhosis, interstitial lung disease, or psychiatric illness/social situations in the three months prior to registration that would limit compliance with study requirements
  • Patient must not have received prior radiation therapy to >= 25% of the bone marrow for other diseases
  • Patient must not have received prior systemic anthracycline therapy
  • NOTE: Patients who have received prior intravesical therapy at any time for non-muscle invasive urothelial carcinoma of the bladder are eligible
  • Patient must not have either history of or active autoimmune disease requiring immunosuppressive therapy within 2 years prior to registration/randomization or any history of inflammatory bowel disease (inflammatory bowel disease [IBD], e.g. ulcerative colitis, or Crohn's disease), neuromuscular autoimmune condition, immune-related pneumonitis or interstitial lung disease. Patients with well-controlled hyper/hypothyroidism, celiac controlled by diet alone, diabetes mellitus type I, vitiligo, alopecia, psoriasis, eczema, lichen planus, or similar skin/mucosa condition are eligible
  • Patient must not be on or have used immunosuppressive medication within 14 days prior to the first dose of durvalumab. The following are exceptions to this criterion and are allowed:
  • Intranasal, inhaled, intra-auricular, topical steroids, or local steroid injections (e.g. intra-articular injection
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent at the time of enrollment
  • Steroids as pre-medications for hypersensitivity reactions (e.g. computed tomography [CT] pre-medication)
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration/randomization are eligible for this trial
  • NOTE: These patients must be stable on their anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on the same regimen; the most recent undetectable viral load must be within the past 12 weeks. They must have a CD4 count of greater than 250 cells/mcL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count < 200 cells/mcL over the past 2 years, unless it was deemed related to the cancer and/or chemotherapy induced bone marrow suppression. They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months
  • NOTE: For patients who have received chemotherapy in the past 6 months, a CD4 count < 250 cells/mcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy. They must have an undetectable viral load and a CD4 count >= 250 cells/mcL within 7 days of registration/randomization
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • NOTE: Testing for HIV, hepatitis B or hepatitis C is not required unless clinically indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and have undetectable viral load. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
  • Patient must not have received live attenuated vaccine within 30 days prior to the first dose of durvalumab, while on protocol treatment and within 30 days after the last dose of durvalumab
  • Patient must not have had a major surgical procedure within 28 days prior to registration/randomization
  • NOTE: Cystoscopy/ureteroscopy/TURBT, stent placement or nephrostomy tube is not considered major surgery
  • Patient must not have history of allogenic organ transplantation
  • Patient must have a body weight of > 30 kg
  • Patient must have life expectancy of >= 12 weeks
  • Patient must have creatinine clearance > 15 ml/min as estimated by Cockcroft-Gault formula or glomerular filtration rate (GFR) > 15 ml/min/1.73m^2 within 28 days prior to registration/randomization
  • NOTE: Patients will be assigned to cisplatin-ineligible and cisplatin-eligible cohorts based on their creatinine clearance, Eastern Cooperative Oncology Group (ECOG) performance status, and grade (if any) of peripheral neuropathy and/or hearing loss in keeping with recommended cisplatin contraindications. Patients who are cisplatin-eligible will be randomized to either Arm A or Arm B and patients who are cisplatin-ineligible will be registered to Arm C
  • Patients that meet any of the following four criteria will be registered to the cisplatin-ineligible Arm C if they meet other eligibility criteria:
  • Creatinine clearance > 15 ml/min and =< 50 ml/min (estimated by Cockcroft-Gault formula) or GFR > 15ml/min/1.73m^2 and ≤ 50 ml/min/1.73 m^2
  • Hearing loss >= 3
  • Neuropathy >= 2
  • ECOG performance status 2
  • In addition, the patient must have an absolute neutrophil count (ANC) >= 1,000/mcL obtained =< 14 days prior to registration
  • Patients that meet all of the following four criteria will be randomized to the cisplatin-eligible Arm A or Arm B:
  • Creatinine clearance > 50ml/min (estimated by Cockcroft-Gault formula) or GFR > 50ml/min/1.73m^2
  • ECOG performance status 0-1
  • Hearing loss grade 0-2
  • Neuropathy 0-1
  • In addition, the patient must have an absolute neutrophil count (ANC) >= 1,500/mcL obtained =< 14 days prior to randomization
  • Also, the patient must have left ventricular ejection fraction (LVEF) >= 50% by (either multigated acquisition scan [MUGA] or 2-D echocardiogram) obtained within obtained within 28 days prior to randomization

Who cannot join

None listed.

Trial locations and contacts

258 sites in 1 country. Contact the study team or a site near you to ask about taking part.

258 sites in 1 country

United States258 sites, 152 recruiting

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

    Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu

    Amy C. Tarnower

    Recruiting

  • OSF Saint Anthony's Health Center

    Alton, Illinois, 62002

    Suspended

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

    Active, not recruiting

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

    Active, not recruiting

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

    Site Public Contact, 920-364-3604, ResearchDept@thedacare.org

    Matthias Weiss

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    Jacqueline T. Brown

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Site Public Contact, 404-778-1868

    Jacqueline T. Brown

    Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Site Public Contact, 404-851-7115

    Jacqueline T. Brown

    Recruiting

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

    Active, not recruiting

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

    Site Public Contact, 207-626-4855

    Erin Adler

    Recruiting

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

    Site Public Contact, 720-848-0650

    Elizabeth R. Kessler

    Recruiting

  • Mercy Oncology and Hematology - Clayton-Clarkson

    Ballwin, Missouri, 63011

    Suspended

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

    Site Public Contact, 410-955-8804, jhcccro@jhmi.edu

    Jean H. Hoffman-Censits

    Recruiting

  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010

    Site Public Contact, 847-842-4847

    Thomas J. Saphner

    Recruiting

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

    Site Public Contact, 225-215-1353, clinicalresearch@marybird.com

    Victor T. Lin

    Recruiting

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

    Active, not recruiting

  • University of Iowa Healthcare Cancer Services Quad Cities

    Bettendorf, Iowa, 52722

    Site Public Contact, 563-355-7733, katherine-daprile@uiowa.edu

    Fernando Maciel Barbosa

    Recruiting

  • MaineHealth Maine Medical Center - Biddeford

    Biddeford, Maine, 04005

    Suspended

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

    Active, not recruiting

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

    Suspended

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

    Active, not recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Active, not recruiting

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

    Suspended

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

    Suspended

  • Loyola Center for Health at Burr Ridge

    Burr Ridge, Illinois, 60527

    Active, not recruiting

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

    Suspended

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

    Active, not recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

    Suspended

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 573-334-2230, sfmc@sfmc.net

    Bryan A. Faller

    Recruiting

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

    Suspended

  • SIH Cancer Institute

    Carterville, Illinois, 62918

    Site Public Contact, 618-985-3333, clinical.research@sih.net

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

    Active, not recruiting

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

    Active, not recruiting

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

    Suspended

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Active, not recruiting

  • Vandalia Health/CAMC Institute for Academic Medicine

    Charleston, West Virginia, 25304

    Site Public Contact, 304-388-9944, CAMCClinicalTrials@vandaliahealth.org

    Kok Hoe Chan

    Recruiting

  • Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

    Site Public Contact, 773-296-5360

    Thomas J. Saphner

    Recruiting

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

    Suspended

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

    Site Public Contact, 919-587-9084, jfields@cancersmoc.com

    Samer S. Kasbari

    Recruiting

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • AMG Crystal Lake - Oncology

    Crystal Lake, Illinois, 60014

    Site Public Contact, 630-929-6129, advocateresearch@advocate.com

    Thomas J. Saphner

    Recruiting

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

    Site Public Contact, 214-590-5582, canceranswerline@UTSouthwestern.edu

    Vitaly Margulis

    Recruiting

  • UT Southwestern Simmons Cancer Center - RedBird

    Dallas, Texas, 75237

    Suspended

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Vitaly Margulis

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

    Site Public Contact, 800-446-5532, Research@Carle.com

    Prem Sobti

    Recruiting

  • Miami Valley Hospital

    Dayton, Ohio, 45409

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Premier Blood and Cancer Center

    Dayton, Ohio, 45409

    Site Public Contact, 937-276-8320

    Tarek M. Sabagh

    Recruiting

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

    Active, not recruiting

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Emory Decatur Hospital

    Decatur, Georgia, 30033

    Site Public Contact, 440-778-1868, clinicaltrialsoncology@dekalbmedical.org

    Jacqueline T. Brown

    Recruiting

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

    Suspended

  • UCHealth - Cherry Creek

    Denver, Colorado, 80206

    Site Public Contact, ecog.rss@jimmy.harvard.edu

    Elizabeth R. Kessler

    Recruiting

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

    Active, not recruiting

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

    Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com

    Thomas J. Saphner

    Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Active, not recruiting

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Seth O. Fagbemi

    Recruiting

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

    Suspended

  • Minnesota Oncology - Edina

    Edina, Minnesota, 55435

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Site Public Contact, 800-446-5532, Research@carle.com

    Prem Sobti

    Recruiting

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

    Site Public Contact, 847-429-2907

    Thomas J. Saphner

    Recruiting

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Leonard J. Appleman

    Recruiting

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

    Active, not recruiting

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

    Active, not recruiting

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Elie G. Dib

    Recruiting

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

    Suspended

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Elie G. Dib

    Recruiting

  • Hurley Medical Center

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Elie G. Dib

    Recruiting

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

    Site Public Contact, 970-297-6150

    Elizabeth R. Kessler

    Recruiting

  • Cancer Care and Hematology-Fort Collins

    Fort Collins, Colorado, 80528

    Site Public Contact, ecog.rss@jimmy.harvard.edu

    Elizabeth R. Kessler

    Recruiting

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501

    Active, not recruiting

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

    Suspended

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    Fort Worth, Texas, 76104

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Vitaly Margulis

    Recruiting

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

    Active, not recruiting

  • Palo Alto Medical Foundation-Fremont

    Fremont, California, 94538

    Active, not recruiting

  • Unity Hospital

    Fridley, Minnesota, 55432

    Active, not recruiting

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

    Active, not recruiting

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

    Suspended

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

    Suspended

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

    Site Public Contact, 919-587-9084, jfields@cancersmoc.com

    Samer S. Kasbari

    Recruiting

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

    Suspended

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80631

    Site Public Contact, ecog.rss@jimmy.harvard.edu

    Elizabeth R. Kessler

    Recruiting

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

    Site Public Contact, 724-838-1900

    Leonard J. Appleman

    Recruiting

  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331

    Site Public Contact, 937-569-7515

    Tarek M. Sabagh

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Completed

  • Advocate South Suburban Hospital

    Hazel Crest, Illinois, 60429

    Site Public Contact, 708-799-9995

    Thomas J. Saphner

    Recruiting

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

    Site Public Contact, 717-531-3779, CTO@hmc.psu.edu

    Monika Joshi

    Recruiting

  • UCHealth Highlands Ranch Hospital

    Highlands Ranch, Colorado, 80129

    Site Public Contact, 720-848-0650

    Elizabeth R. Kessler

    Recruiting

  • Loyola Medicine Homer Glen

    Homer Glen, Illinois, 60491

    Active, not recruiting

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

    Site Public Contact, 800-237-1225

    Fernando Maciel Barbosa

    Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

    Active, not recruiting

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

    Site Public Contact, 910-587-9084, jfields@cancersmoc.com

    Samer S. Kasbari

    Recruiting

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129

    Active, not recruiting

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

    Suspended

  • Freeman Health System

    Joplin, Missouri, 64804

    Suspended

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

    Suspended

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

    Active, not recruiting

  • Kettering Medical Center

    Kettering, Ohio, 45429

    Active, not recruiting

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

    Active, not recruiting

  • Kingman Regional Medical Center

    Kingman, Arizona, 86401

    Site Public Contact, 702-384-0013, research@sncrf.org

    Khawaja S. Jahangir

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

    Site Public Contact, 858-822-5354, cancercto@ucsd.edu

    Aditya Bagrodia

    Recruiting

  • OptumCare Cancer Care at Charleston

    Las Vegas, Nevada, 89102

    Suspended

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89183

    Suspended

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

    Site Public Contact, 877-231-4440

    Adanma Anji Ayanambakkam Attanathi

    Recruiting

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

    Site Public Contact, 859-257-3379

    Patrick J. Hensley

    Recruiting

  • AMG Libertyville - Oncology

    Libertyville, Illinois, 60048

    Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com

    Thomas J. Saphner

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Active, not recruiting

  • Cooperman Barnabas Medical Center

    Livingston, New Jersey, 07039

    Site Public Contact, 973-322-5200

    Saum B. Ghodoussipour

    Recruiting

  • Hope Cancer Clinic

    Livonia, Michigan, 48154

    Suspended

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • UCHealth Lone Tree Health Center

    Lone Tree, Colorado, 80124

    Site Public Contact, ecog.rss@jimmy.harvard.edu

    Elizabeth R. Kessler

    Recruiting

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

    Site Public Contact, 970-203-7083

    Elizabeth R. Kessler

    Recruiting

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

    Active, not recruiting

  • Henry Ford Saint John Hospital - Macomb Medical

    Macomb, Michigan, 48044

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Elie G. Dib

    Recruiting

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

    Suspended

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

    Suspended

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • McFarland Clinic - Marshalltown

    Marshalltown, Iowa, 50158

    Active, not recruiting

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Seth O. Fagbemi

    Recruiting

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

    Site Public Contact, 800-446-5532, Research@carle.com

    Prem Sobti

    Recruiting

  • Loyola University Medical Center

    Maywood, Illinois, 60153

    Active, not recruiting

  • Marjorie Weinberg Cancer Center at Loyola-Gottlieb

    Melrose Park, Illinois, 60160

    Active, not recruiting

  • Mary Bird Perkins Cancer Center - Metairie

    Metairie, Louisiana, 70002

    Site Public Contact, 504-584-6990

    Victor T. Lin

    Recruiting

  • East Jefferson General Hospital

    Metairie, Louisiana, 70006

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Rajasree P. Chowdry

    Recruiting

  • LSU Healthcare Network / Metairie Multi-Specialty Clinic

    Metairie, Louisiana, 70006

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Rajasree P. Chowdry

    Recruiting

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

    Suspended

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

    Suspended

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

    Suspended

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Seth O. Fagbemi

    Recruiting

  • Memorial Medical Center

    Modesto, California, 95355

    Active, not recruiting

  • UPMC Hillman Cancer Center - Monroeville

    Monroeville, Pennsylvania, 15146

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Leonard J. Appleman

    Recruiting

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

    Suspended

  • SSM Health Good Samaritan

    Mount Vernon, Illinois, 62864

    Site Public Contact, 618-899-1894, gayla.hall@ssmhealth.com

    Jay W. Carlson

    Recruiting

  • Palo Alto Medical Foundation-Camino Division

    Mountain View, California, 94040

    Active, not recruiting

  • ProHealth D N Greenwald Center

    Mukwonago, Wisconsin, 53149

    Site Public Contact, research.institute@phci.org

    Timothy R. Wassenaar

    Recruiting

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    Elie G. Dib

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

    Site Public Contact, 732-235-7356

    Saum B. Ghodoussipour

    Recruiting

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Rajasree P. Chowdry

    Recruiting

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

    Suspended

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

    Suspended

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453-2699

    Site Public Contact, 800-323-8622

    Thomas J. Saphner

    Recruiting

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

    Site Public Contact, 262-928-7878

    Timothy R. Wassenaar

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Adanma Anji Ayanambakkam Attanathi

    Recruiting

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

    Suspended

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

    Active, not recruiting

  • Palo Alto Medical Foundation Health Care

    Palo Alto, California, 94301

    Active, not recruiting

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

    Site Public Contact, 650-498-7061, cancertrialsinfo@stanford.edu

    Ali R. Khaki

    Recruiting

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

    Site Public Contact, 847-384-3621

    Thomas J. Saphner

    Recruiting

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

    Active, not recruiting

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

    Active, not recruiting

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

    Suspended

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

    Active, not recruiting

  • Valley Radiation Oncology

    Peru, Illinois, 61354

    Suspended

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

    Site Public Contact, 215-349-8245, PMCancerResearch@pennmedicine.upenn.edu

    Ronac Mamtani

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    William J. Tester

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Site Public Contact, 412-647-8073

    Leonard J. Appleman

    Recruiting

  • UPMC-Passavant Hospital

    Pittsburgh, Pennsylvania, 15237

    Site Public Contact, 412-367-6454

    Leonard J. Appleman

    Recruiting

  • UPMC-Saint Clair Hospital Cancer Center

    Pittsburgh, Pennsylvania, 15243

    Site Public Contact, 412-502-3920

    Leonard J. Appleman

    Recruiting

  • Michigan Healthcare Professionals Pontiac

    Pontiac, Michigan, 48341

    Site Public Contact, 248-858-6215, Emily.Crofts@trinity-health.org

    Elie G. Dib

    Recruiting

  • Trinity Health IHA Medical Group-Alice Gustafson Center

    Pontiac, Michigan, 48341

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

    Active, not recruiting

  • Fairview Northland Medical Center

    Princeton, Minnesota, 55371

    Suspended

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Seth O. Fagbemi

    Recruiting

  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas, 75080

    Site Public Contact, 972-669-7044, Suzanne.cole@utsouthwestern.edu

    Vitaly Margulis

    Recruiting

  • Reid Health

    Richmond, Indiana, 47374

    Active, not recruiting

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

    Suspended

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Site Public Contact, 855-776-0015

    Lance C. Pagliaro

    Recruiting

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

    Suspended

  • Phelps Health Delbert Day Cancer Institute

    Rolla, Missouri, 65401

    Suspended

  • Sutter Roseville Medical Center

    Roseville, California, 95661

    Active, not recruiting

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

    Active, not recruiting

  • MyMichigan Medical Center Saginaw

    Saginaw, Michigan, 48601

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Oncology Hematology Associates of Saginaw Valley PC

    Saginaw, Michigan, 48604

    Suspended

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

    Suspended

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Regions Hospital

    Saint Paul, Minnesota, 55101

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • United Hospital

    Saint Paul, Minnesota, 55102

    Suspended

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • UC San Diego Medical Center - Hillcrest

    San Diego, California, 92103

    Site Public Contact, rhabbaba@health.ucsd.edu

    Aditya Bagrodia

    Recruiting

  • California Pacific Medical Center-Pacific Campus

    San Francisco, California, 94115

    Active, not recruiting

  • MaineHealth Cancer Care and IV Therapy - Sanford

    Sanford, Maine, 04073

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Erin Adler

    Recruiting

  • MaineHealth Cancer Care Center of York County

    Sanford, Maine, 04073

    Site Public Contact, 207-459-1600

    Erin Adler

    Recruiting

  • Palo Alto Medical Foundation-Santa Cruz

    Santa Cruz, California, 95065

    Active, not recruiting

  • Sutter Pacific Medical Foundation

    Santa Rosa, California, 95403

    Active, not recruiting

  • MaineHealth Maine Medical Center- Scarborough

    Scarborough, Maine, 04074

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Erin Adler

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Site Public Contact, 800-804-8824

    Petros Grivas

    Recruiting

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

    Site Public Contact, 800-804-8824

    Petros Grivas

    Recruiting

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

    Suspended

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • MaineHealth Cancer Care and IV Therapy - South Portland

    South Portland, Maine, 04106

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Erin Adler

    Recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

    Site Public Contact, 217-545-7929

    Bryan A. Faller

    Recruiting

  • Springfield Clinic

    Springfield, Illinois, 62702

    Site Public Contact, 800-444-7541

    Bryan A. Faller

    Recruiting

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

    Suspended

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

    Suspended

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

    Suspended

  • Springfield Regional Cancer Center

    Springfield, Ohio, 45504

    Suspended

  • Mercy Infusion Center - Chippewa

    St Louis, Missouri, 63109

    Suspended

  • Mercy Hospital South

    St Louis, Missouri, 63128

    Site Public Contact, 314-525-6042, Danielle.Werle@mercy.net

    Jay W. Carlson

    Recruiting

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

    Site Public Contact, 314-251-7066

    Jay W. Carlson

    Recruiting

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Seth O. Fagbemi

    Recruiting

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Palo Alto Medical Foundation-Sunnyvale

    Sunnyvale, California, 94086

    Active, not recruiting

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

    Site Public Contact, 419-824-1842, PCIOncResearch@promedica.org

    Jeffrey H. Muler

    Recruiting

  • MyMichigan Medical Center Tawas

    Tawas City, Michigan, 48764

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Community Medical Center

    Toms River, New Jersey, 08755

    Site Public Contact, 732-557-8294, Lennette.Gonzales@rwjbh.org

    Saum B. Ghodoussipour

    Recruiting

  • Upper Valley Medical Center

    Troy, Ohio, 45373

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Carle Cancer Center

    Urbana, Illinois, 61801

    Site Public Contact, 800-446-5532, Research@carle.com

    Prem Sobti

    Recruiting

  • Sutter Solano Medical Center/Cancer Center

    Vallejo, California, 94589

    Active, not recruiting

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

    Suspended

  • Illinois CancerCare - Washington

    Washington, Illinois, 61571

    Active, not recruiting

  • Mercy Hospital Washington

    Washington, Missouri, 63090

    Suspended

  • UPMC Cancer Center-Washington

    Washington, Pennsylvania, 15301

    Site Public Contact, ecog.rss@jimmy.harvard.edu

    Leonard J. Appleman

    Recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    Site Public Contact, 202-877-8839

    Suthee Rapisuwon

    Recruiting

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

    Site Public Contact, 202-243-2373, jquiver1@jhmi.edu

    Jean H. Hoffman-Censits

    Recruiting

  • ProHealth Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

    Site Public Contact, 262-928-7632

    Timothy R. Wassenaar

    Recruiting

  • UW Cancer Center at ProHealth Care

    Waukesha, Wisconsin, 53188

    Site Public Contact, 262-928-5539, Chanda.miller@phci.org

    Timothy R. Wassenaar

    Recruiting

  • ThedaCare Cancer Care - Waupaca

    Waupaca, Wisconsin, 54981

    Site Public Contact, 920-364-3605, ResearchDept@thedacare.org

    Matthias Weiss

    Recruiting

  • Aurora Cancer Care-Milwaukee West

    Wauwatosa, Wisconsin, 53226

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Saint Mary's Oncology/Hematology Associates of West Branch

    West Branch, Michigan, 48661

    Suspended

  • Reading Hospital

    West Reading, Pennsylvania, 19611

    Site Public Contact, 610-988-9323

    Terrence P. Cescon

    Recruiting

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Seth O. Fagbemi

    Recruiting

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

    Suspended

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

    Active, not recruiting

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • UMass Memorial Medical Center - University Campus

    Worcester, Massachusetts, 01655

    Site Public Contact, 508-856-3216, cancer.research@umassmed.edu

    Kriti Mittal

    Recruiting

  • Fairview Lakes Medical Center

    Wyoming, Minnesota, 55092

    Suspended

  • Huron Gastroenterology PC

    Ypsilanti, Michigan, 48106

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    Ypsilanti, Michigan, 48197

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

Other trials in United States

About this study

Official title: A Phase II/III Trial of Durvalumab and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare event-free survival (EFS) between patients with upper tract urothelial cancer (UTUC) randomized to neoadjuvant accelerated methotrexate, vinblastine, Adriamycin, cisplatin (aMVAC) alone or in combination with durvalumab. (Cisplatin eligible patients [Arms A and B]) II. Evaluation of pathologic complete response at radical nephroureterectomy (RNU) (pathologic complete response [pCR], ypT0N0/Nx). (Cisplatin ineligible patients [Arm C]).

SECONDARY OBJECTIVES:

  1. To assess pathologic complete response (pCR) at surgery. (Cisplatin eligible cohort) II. Event-free survival (EFS) will be evaluated for the cisplatin ineligible cohort as a secondary endpoint. (Cisplatin ineligible cohort) III. Overall survival in all, and by post chemotherapy response (ypT0N0, yp =< T1N0, yp >= T2Nany). (All patients) IV. To evaluate disease-free survival (DFS) in each arm of the trial separately. (All patients) V. To evaluate cancer-specific survival of patients in each arm of the trial separately. (All patients) VI. To evaluate renal function outcomes following systemic treatment and following surgery ([RNU) in each arm of the trial separately. (All patients) VII. To evaluate safety and tolerability of neoadjuvant aMVAC alone or in combination with durvalumab prior to RNU. (All patients)

OUTLINE: Patients eligible for cisplatin are randomized to Arms A or B. Patients ineligible for cisplatin are assigned to Arm C.

ARM A: Patients receive durvalumab intravenously (IV) over 60 minutes on day 1 of chemotherapy cycles 1 and 3. Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery.

ARM B: Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery.

ARM C: Patients receive durvalumab IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery.

Patients also undergo tissue biopsy and blood sample collection on study, and computed tomography (CT) or magnetic resonance imaging (MRI) throughout the trial.

After completion of study treatment, patients are followed up within 30 days and then every 3-6 months for up to 5 years from study entry.

Being tested
Biopsy Procedure, Biospecimen Collection, Cisplatin, Computed Tomography, Doxorubicin Hydrochloride

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo tissue biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Doxorubicin HydrochlorideDrug

    Also called 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin

    Given Iv

  • DurvalumabBiological

    Also called Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI 4736, MEDI-4736

    Given IV

  • Gemcitabine HydrochlorideDrug

    Also called dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemcitabine HCI, Gemzar

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • MethotrexateDrug

    Also called Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate

    Given IV

  • PegfilgrastimBiological

    Also called Cegfila, Dulastin, Dyrupeg, Filgrastim SD-01

    Given via injection

  • Therapeutic Conventional SurgeryProcedure or surgery

    Undergo surgery

  • Vinblastine SulfateDrug

    Also called 29060 LE, 29060-LE, Exal, Velban

    Given Iv

Study groups in NCT04628767
Study groupRoleWhat they receive
Arm A (durvalumab, chemotherapy)ExperimentalPatients receive durvalumab IV over 60 minutes on day 1 of chemotherapy cycles 1 and 3. Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. Patients also undergo tissue biopsy and blood sample collection on study, and CT or MRI throughout the trial.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Doxorubicin Hydrochloride; Biological: Durvalumab; Procedure: Magnetic Resonance Imaging; Drug: Methotrexate; Biological: Pegfilgrastim; Procedure: Therapeutic Conventional Surgery; Drug: Vinblastine Sulfate
Arm B (chemotherapy)Active comparatorPatients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. Patients also undergo tissue biopsy and blood sample collection on study, and CT or MRI throughout the trial.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Doxorubicin Hydrochloride; Procedure: Magnetic Resonance Imaging; Drug: Methotrexate; Biological: Pegfilgrastim; Procedure: Therapeutic Conventional Surgery; Drug: Vinblastine Sulfate
Arm C (durvalumab, gemcitabine hydrochloride)ExperimentalPatients receive durvalumab IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. Patients also undergo tissue biopsy and blood sample collection on study, and CT or MRI throughout the trial.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Durvalumab; Drug: Gemcitabine Hydrochloride; Procedure: Magnetic Resonance Imaging; Procedure: Therapeutic Conventional Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival (EFS) (Cisplatin eligible cohort: Arms A and B)

    Disease progression prior to surgery or omission of surgery due to unresectable tumors, muscle-invasive cancer or disease recurring outside of the bladder, urethra, or contralateral upper tract are considered as events for EFS.

    Measured: From registration/randomization to the earliest of systemic recurrence outside urinary tract, cancer progression, or death from any cause, assessed up to 5 years

  2. Pathologic complete response (pCR) (Cisplatin ineligible cohort: Arm C)

    Will assess pathologic complete response at surgery (pCR, pT0N0/Nx) by local pathology review. Patients who drop out prior to surgery or who have unknown response status will be considered as non-responders.

    Measured: At surgery

Secondary outcomes (7)

  1. pCR (Cisplatin-eligible cohort: Arms A and B)

    Measured: Up to 5 years

  2. EFS (cisplatin-ineligible cohort: Arm C)

    Will be characterized using the Kaplan-Meier method.

    Measured: From registration/randomization to the earliest of systemic recurrence outside urinary tract, cancer progression, or death from any cause, assessed up to 5 years

  3. Overall survival (OS) (All Patients)

    OS will be evaluated by arm, post chemotherapy response (ypCR, stage yp =< T1N0, yp >= T2N0), as well as stage (ypCR and > ypCR) within and across treatment arms. Will be estimated using Kaplan-Meier method.

    Measured: From registration/randomization to death from any cause, assessed up to 5 years

  4. Urothelial cancer-free survival or disease-free survival (All Patients)

    A return of UTUC includes non-muscle invasive recurrences, pathologic T2 or higher muscle-invasive recurrences specifically in the urinary tract, metastatic disease outside the urinary tract, or death. Patients alive without documented UTUC will be censored at the date of last disease assessment.

    Measured: From the date of surgery to the earlier of a return of upper tract urothelial cancer (UTUC) or death from any cause, assessed up to 5 years

  5. Cancer-specific survival (All Patients)

    Will be analyzed using Gray's method and cumulative incidence estimates will be reported.

    Measured: From registration/randomization to death due to cancer; deaths due to other causes will be counted as competing events, assessed up to 5 years

  6. Renal function outcomes following systemic treatment and following radical nephroureterectomy (All Patients)

    The proportion of patients with renal insufficiency (creatinine [CrCl] < 60 ml/min) post chemotherapy and post nephroureterectomy as well as the proportion of patients with renal function improvement (CrCl < 60 ml/min at baseline and CrCl >= 60 ml/min on study) will be reported along with exact binomial confidence intervals. The distribution of changes in renal function post chemotherapy as well as post surgery from baseline will also be reported. The analysis of renal function outcomes will be performed among patients who receive at least one dose of study therapy.

    Measured: Post chemotherapy and post surgery

  7. Incidence of adverse events (All Patients)

    Toxicity will be evaluated in all treated patients.

    Measured: Up to 30 days post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2020
  2. Study start12 Nov 2021
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
131 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04628767
Sponsor's protocol ID
NCI-2020-09850
Other IDs
NCI-2020-09850, EA8192, EA8192, U10CA180820
Status last verified
Jul 2026
First submitted
13 Nov 2020
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Biopsy Procedure, Biospecimen Collection and Cisplatin in people with Renal Pelvis and Ureter Urothelial Carcinoma, run by National Cancer Institute (NCI) at 258 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 66 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 258 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival (EFS) (Cisplatin eligible cohort: Arms A and B) (time frame: From registration/randomization to the earliest of systemic recurrence outside urinary tract, cancer progression, or death from any cause, assessed up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04628767.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in